Back to search

United States· US:60505-0953_7497532a-03c9-9016-0df5-6d3acfc3b29b

Azelastine hydrochloride and Fluticasone propionate

A medicinal product containing azelastine hydrochloride; fluticasone propionate, registered in United States by Apotex Corp..

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAzelastine hydrochloride and Fluticas…ATC—REGISTER NO.US:60505-0953_7497532…PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Manufacturer
Apotex Corp.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 1

  • ndc11
    60505-0953-3

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Azelastine hydrochloride; fluticasone propionate in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All azelastine hydrochloride; fluticasone propionate products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Azelastin/Fluticason Orifarm, Azelastin/Fluticason Ratiopharm
  • Bulgaria · Azelastine/Fluticasone Pharmascience, Димиста
  • Cyprus · Azemista, Bileni
  • Czechia · Azelastin/Flutikason Teva, Dymistin
  • Germany · Allergo-Duolind, Azeflunal
  • Denmark · Azecort, Azeflone
  • Estonia · Azelastine/Fluticasone Teva, Azelastine/Fluticasone Zentiva
  • Spain · Arespinduo, Avancort Duo
  • Finland · Acirasi, Allestin
  • France · Azaflunex, Azelastine Chlorhydrate / Fluticasone Propionate Biogaran
  • United Kingdom (Northern Ireland) · Adsego, Allenasal Duo
  • Greece · Azelastine+fluticasone Win Medica, Azemista
  • Croatia · Dymista, Fogilix
  • Hungary · Azelastine/Fluticasone Stada, Azelasztin/Flutikazon
  • Ireland · Azecort, Azelastine Hydrochloride/Fluticasone Propionate Rowex
  • Iceland · Azecort, Duonasa Nefúði
  • Italy · Azefluxin, Azelastina E Fluticasone
  • Lithuania · Azavin, Azecort
  • Luxembourg · Dymista, Dymista Nasenspray
  • Latvia · Azecort, Azelastine/Fluticasone Teva
  • Malta · Azecort, Dymista
  • Netherlands · Azelastine Hydrochloride & Fluticasone Propionate Viatris Healthcare, Azelastine/Fluticasonpropionaat
  • Norway · Altimista, Azeflone
  • Poland · Allerduo, Azaneson
  • Portugal · Azecort, Azelastina + Fluticasona
  • Romania · Dymista, Lutonaze
  • Sweden · Azeflone Stada, Azelastin/Flutikason Teva
  • Slovenia · Dymista, Dymol
  • Slovakia · Azecort, Azelastín/Flutikazón Stada

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/143fb4c8-ceb7-424a-9c48-013541172111
GET /v1/drugs/143fb4c8-ceb7-424a-9c48-013541172111?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "NASAL",
  "source": "ndc",
  "strength": "137; 50",
  "substance": "AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE",
  "productndc": "60505-0953",
  "dosage_form": "SPRAY, METERED",
  "dea_schedule": null,
  "strength_unit": "ug/1; ug/1",
  "application_number": "ANDA207712",
  "marketing_category": "ANDA"
}

See everything about azelastine hydrochloride; fluticasone propionate.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.